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The Journal of Clinical Endocrinology & Metabolism Vol. 89, No. 5 2085-2098
Copyright © 2004 by The Endocrine Society

Long-Term Testosterone Gel (AndroGel) Treatment Maintains Beneficial Effects on Sexual Function and Mood, Lean and Fat Mass, and Bone Mineral Density in Hypogonadal Men

Christina Wang, Glenn Cunningham, Adrian Dobs, Ali Iranmanesh, Alvin M. Matsumoto, Peter J. Snyder, Thomas Weber, Nancy Berman, Laura Hull and Ronald S. Swerdloff

Division of Endocrinology (C.W., N.B., L.H., R.S.S.), Departments of Medicine/Pediatrics, Harbor-University of California, Los Angeles Medical Center and Research and Education Institute, Torrance, California 90509; Veterans Affairs Medical Center (G.C.), Baylor College of Medicine, Houston, Texas 77030; Johns Hopkins University (A.D.), Baltimore, Maryland 21287; Veterans Affairs Medical Center (A.I.), Salem, Virginia 24153; Geriatric Research (A.M.M.), Education and Clinical Center, Veterans Affairs Puget Sound Health Care System, University of Washington, Seattle, Washington 98108; University of Pennsylvania Medical Center (P.J.S.), Philadelphia, Pennsylvania 19104; and Duke University Medical Center (T.W.), Durham, North Carolina 27705

Address all correspondence and requests for reprints to: Christina Wang, M.D., General Clinical Research Center, Harbor-UCLA Medical Center, 1000 West Carson Street, Torrance, California 90509-2910. E-mail: wang{at}gcrc.rei.edu.

Transdermal testosterone (T) delivery represents an effective alternative to injectable androgens. We studied 163 hypogonadal men who applied 5, 7.5, or 10 g AndroGel (T gel) 1% CIII per day for up to 42 months. Efficacy data were presented in 123 subjects considered evaluable. Continuous AndroGel treatment normalized mean serum T and free T levels. Mean serum 5{alpha}-dihydrotestosterone concentrations and 5{alpha}-dihydrotestosterone/T ratio slightly increased, mean serum estradiol/T ratio doubled, and mean serum FSH and LH levels were suppressed by T replacement. Sexual function and mood parameters improved rapidly and were maintained throughout T treatment. Lean body mass increased (P = 0.0001) and fat mass decreased (P = 0.0001), and these changes were maintained with treatment but were not accompanied by significant increases in muscle strength. Increases in serum bone markers suggestive of increased bone formation were followed by gradual and progressive increases in bone mineral density more in the spine (P = 0.0001) than the hip (P = 0.0004). Mild local skin irritation occurred in 12 subjects, resulting in discontinuation in only one subject. Except for the anticipated increase in hematocrit and hemoglobin, there were no clinically significant changes in blood counts or biochemistry. In three subjects with elevated serum prostate-specific antigen, prostate biopsies showed cancer. We conclude that continued application of AndroGel resulted in beneficial effects similar to those with injectables and other transdermal preparations. This study was neither placebo controlled nor powered to determine the effects of T treatment on prostate cancer risk. Thus, monitoring for prostatic disease and assessment for erythrocytosis are strongly advised to reduce the risk of adverse events with T treatment of hypogonadal men.

This work was supported by grants from Solvay Pharmaceuticals.

This study was presented in part at the 84th Annual Meeting of The Endocrine Society, San Francisco, California, 2002.

Abbreviations: BCE, Bone collagen equivalent; BMD, bone mineral density; Ca, calcium; Cr, creatinine; CV, coefficient of variation; DHT, 5{alpha}-dihydrotestosterone; E2, estradiol; HDL, high-density lipoprotein; IPSS, International Prostate Symptom Score; IRMA, immunoradiometric assay; LDL, low-density lipoprotein; LOQ, limit of quantitation; N-telopeptide, urine type I collagen cross-linked N-telopeptide; PSA, prostatic-specific antigen; SALP, skeletal-specific alkaline phosphatase; T, testosterone.




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